A history of any surgical abdominal intervention (including appendectomy) or of peritonitis

Bronchial asthma, COPD, or actual obstructive bronchitis

Hypothyroidism /hyperthyroidism

Cardiac insufficiency

Liver disease

Cardiac dysrhythmia (e.g., prolongation of the QT interval)

Diabetes mellitus

Chronic infections

Relevant acute infections or with actual therapy-requiring allergies (including drug allergies) within the last two weeks

Suspicion of hypersensitivity to sunitinib or to any of the excipients

Any clinically relevant laboratory abnormality

Subjects receiving any medication within 2 weeks prior to study start or during the study (exceptions possible upon decision of Principal Investigator, e.g., paracetamol (acetaminophen) single dose for acute pain or topical aciclovir for herpes simplex)

Subjects who have taken a drug with a long half-life (> 24 hours) within four weeks before the first trial day

Subjects who received chronic drug treatment (> 3 days) within eight weeks before the first trial day

Subjects who participated in a clinical trial within the last 3 months before the start of the present study

Subjects who donated blood or plasma within the last 12 weeks before the start of the present study

Subjects who smoke, i.e., subjects who smoked one or more cigarettes during the last six months

Subjects who are known or suspected to be (social) drug dependent, incl. those drinking more than 30 g alcohol per day

Subjects with a history of alcohol or recreational drug addiction

Subjects with a history of any severe disease that might interfere with the study objectives (e.g. psychiatric disease, epilepsy)

Subjects who are not willing or able to abstain from alcohol, methylxanthine-containing beverages and foods, and grapefruit flesh/juice for 72 hours before first study drug administration until 2 weeks after last study drug administration

Subjects who adhere to a special diet (e.g., vegetarians) or lifestyle (including working at night and extreme physical activities such as competitive sports and weight lifting) that might interfere with the investigation

Subjects planning elective hospital treatment within two months after last intake of trial medication

Subjects who are known or suspected not to comply with the study directives and/or known or suspected not to be reliable or trustworthy

Subjects who are known or suspected not to be capable of understanding and evaluating the information that is given to them as part of the formal information policy (informed consent), in particular regarding the foreseeable risks and discomfort to which they will be exposed

Subjects with anticipated problems of successfully placing an indwelling venous catheter at a forearm

Female subjects only:

positive results in pregnancy test

pregnant and lactating women

subjects who do not use or does not agree to use appropriate contraceptive methods during the study and two months after the study

Male subjects only: they have to accept not to procreate children during the study and two months after the study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.